Process/Cleaning Validation (PV/CLV)

Validation refers to activities performed in relation to various processes, including:

[Manufacturing] Process Validation
Cleaning Validation
Analytical Method Validation

During process validation, the robustness of the manufacturing process is verified for each product, ensuring that the process reliably and reproducibly produces a product of the expected quality.

Cleaning validation confirms the ability of the cleaning process applied to equipment or facilities to reliably and reproducibly achieve the required level of cleanliness.

In analytical method validation, the capability of analytical methods to reliably and reproducibly perform their intended tasks is assessed. This includes methods used for testing raw materials, in-process controls, finished product testing, cleaning control, and other types of validation.

These three types of validation are associated with specific processes, so they can collectively be referred to as process validation to distinguish them from the broader concept of validation, which encompasses the entire set of validation activities, including qualification.

Process validation is carried out using real products or materials, or their surrogates. During validation, the actual manufacturing and auxiliary processes are tested to ensure they consistently and reproducibly lead to the expected results.

While operational qualification (OQ) and performance qualification (PQ) focus primarily on equipment and systems, validation focuses on the product and its movement through the process chain.

Validation can be classified based on the time of its execution:

Prospective Validation (performed before start of product manufacturing)
Concurrent Validation (performed during ongoing production)
Retrospective Validation (for established processes that have not yet been validated)

Validation should always be performed prospectively. Concurrent and retrospective validation is allowed only in exceptional cases, as specifically mentioned in regulatory guidelines, and must be thoroughly documented and justified.

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definitions related to process validation:

“…Cleaning Validation: Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.

Process Validation: The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

Prospective Validation: Validation carried out before routine production of products intended for sale…”

Process validation is carried out during the production start-up phase and extends beyond the scope of design processes.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.